Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure
研究概览
简要总结
This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with a combined antiretroviral therapy from at least 1 year
- •Aged 18 years or older
- •With one or more of the following conditions:
- •Grade 3 or 4 Dyslipidemia
- •Any Hyperglycemia
- •Lipodystrophy (patient's self report, confirmed by physician's physical examination)
- •Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)
- •Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week)
- •With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
- •With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
- •Who gave informed consent to the participation to the study
排除标准
- •Pregnancy or breast feeding, desire of pregnancy in the short term
- •Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs.
- •Previous exposure to inhibitors of HIV-1 integrase
- •Previous major toxicity to any of the study drugs
- •Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years
- •Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures
- •Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)
研究组 & 干预措施
Tenofovir Emtricitabine Raltegravir
Patients switching to raltegravir with tenofovir+emtricitabine as backbone
干预措施: tenofovir emtricitabine raltegravir (Drug)
Lamivudine Abacavir Raltegravir
Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
干预措施: Lamivudine Abacavir Raltegravir (Drug)
Abacavir free
Patients switched to raltegravir whose backbone therapy should not be randomized in order to avoid the use of abacavir (HLA-B*5701 positive patients,Framingham score 20% or higher)
干预措施: Abacavir free (Drug)
结局指标
主要结局
To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure
时间窗: 48 weeks
次要结局
- Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis(48 weeks)
- Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis(48 weeks)
- Evolution of CD4 cell count during the 48 weeks of study(48 weeks)
- Evolution of adherence and quality of life during the 48 weeks of study(48 weeks)
- Evolution of raltegravir plasma concentrations during the 48 weeks of study(48 weeks)
- Evolution of metabolic parameters during the 48 weeks of study(48 weeks)
- Change of the results of neurocognitive tests at 48 weeks of study(48 weeks)
- Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study(48 weeks)
研究者
Simona Di Giambenedetto
Dr
Catholic University of the Sacred Heart